Rhinathiol 2% (carbocisteine) Children and Infant Syrup - Contraindication in children below 2 years old

Sanofi-Aventis Singapore Pte Ltd is informing healthcare professionals that they will be adopting the French authorities' decision to contraindicate the use of Rhinathiol 2% Children and Infant syrup in children below 2 years of age. This decision arose from the French Regulatory Agency's (Afssaps) evaluation of pharmacovigilance data which indicated the risk of aggravation of respiratory symptoms in connection with the use of mucolytic products to treat bronchial secretion in children below 2 years old. This led the French authorities to conclude that the benefit risk ratio of mucolytic products in children less than 2 years of age is no longer favourable and the contraindication of these products in this group of children is required as a precautionary measure. The local package insert for Rhinathiol 2% Children and Infant syrup will be updated to reflect this new contraindication. The packaging will subsequently be changed and renamed as Rhinathiol 2% Children Syrup. The new packaging with the revised package insert is estimated to be implemented in Singapore in February 2011.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.